The Tamil Nadu drug controller issued instructions to Chennai-based Global Pharma Healthcare to stop manufacturing all 14 of its products under the ophthalmic category until investigation into the company’s eye drops are completed.

On Friday, Global Pharma had issued an immediate recall of Artificial Tears lubricant eye drops after the US Food and Drug Administration informed the company of 55 cases of adverse events on using the eye drops. The adverse events included eye infection, permanent loss of vision and a death with a bloodstream infection. The cases were recorded between May 2022 till January 2023.

Global Pharma’s manufacturing unit is located in Alathur town of Kanchipuram district in Tamil Nadu. The company manufactures ointments, liquid oral formulations, tablets and exports them to more than 30 countries.

PV Vijayalakshmi, the drug controller of Tamil Nadu, told Scroll that the manufacturing unit for ophthalmic (eye care) products is separate from other categories. “We have only suspended manufacturing activities for ophthalmic products for now,” she said.

On Friday, a team of Tamil Nadu drug officers, including Vijayalakshmi, had visited Global Pharma’s manufacturing unit and drew samples of the finished eye drop from the control batch. A control batch has some samples preserved from each batch if a need for testing arises. Samples of raw material used in manufacturing the particular batch of eye drop were also taken.

“These samples will be tested on priority basis in a government lab here,” Vijayalakshmi said. She, however, did not comment on whether violations in manufacturing process were found in the company. “We will first wait for the lab reports,” she said.

Global Pharma has a World Health Organisation Good Manufacturing Practice certification. The company does contract manufacturing, where in its products are repackaged and relabelled and sold in market.

The Artificial Tears eye drop was exclusively marketed as an over-the-counter drug in United States, said Vijayalakshmi. “This product was not sold domestically,” she added. “They began its manufacturing two years ago.”

Global Pharma has two distributors in the US – Aru Pharma that has labelled the eye drop as Ezricare Artificial Tears, and Delsam Pharma that has labelled the product as Delsam Pharma’s Artificial Tears.

“Delsam Pharma’s product was not included in the complaints,” Kuppusamy Arumugam, from Delsam Pharma, told Scroll over an e-mail. “The item was sold in the US. We had a safety seal on our product bottle. We were not associated with EzriCare and did not purchase the product from the manufacturer at the same time.”

Adverse events due to eye drop

In a multi-state inquiry in the US, the Centers for Disease Control and Prevention linked the eye drop with carbapenem-resistant Pseudomonas aeruginosa infection. It is a bacterial infection that affects the blood and lungs by causing pneumonia and is resistant to an antibiotic called carpabenem.

The Centers for Disease Control and Prevention had collected samples from patients between May 2022 and January 2023. Patients who used the eye drop suffered from inflammation in the cornea, infection in the eyeball, respiratory infection, urinary tract infection, and sepsis. Several patients suffered permanent vision loss.

On February 1, the Centers for Disease Control and Prevention had issued an alert stating that the eye drops had been packaged under the name EzriCare and so far 12 states have reported 55 patients who suffered complications.

These patients reported use of over 10 brands of Artificial Tears and some patients used multiple brands. The EzriCare brand was the most common amongst all patients and identified as a common link from four healthcare facility clusters, the Centers for Disease Control stated.

The organisation drew samples from the open bottle of the eye drop and found presence of bacterial contamination from multiple lots. “These bottles were collected from patients with and without eye infections in two states,” it added.

The bacterial infection in bottle matched with the samples collected from urine, blood, cornea, sputum of patients. The Centers for Disease Control is now in process of testing closed and unused bottles of the eye drop to confirm presence of the bacterial infection. This would prove if the contamination happened during manufacturing stage.

The eye drop, sold in 15 ml bottles, is used to relieve eye irritation and dryness in the eye.